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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve

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  Class 2 Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve see related information
Date Initiated by Firm February 11, 2015
Date Posted March 18, 2015
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-1291-2015
Recall Event ID 70551
510(K)Number K962288  
Product Classification Cover, barrier, protective - Product Code MMP
Product Outer cardboard box labeling:
Pinnacle Cure Sleeve, Curing Light Tip Sleeves.
Kerr Total Care.
Part Number: 4513C or 4513-1
Single Patient Use
Fits 13mm Tips. Pack of 400.

Metrex Research, Manufacturer.

Inner individual packaging of each sleeve:
Cure Sleeve by Pinnacle
Model 4500
Code Information Part Number: 4513C or 4513-1.  Lot Number: 2014030110
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall		 Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
FDA Determined
Cause 2		 Packaging
Action The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.
Quantity in Commerce 172
Distribution Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = PINNACLE PRODUCTS, INC.
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